Study of VARIPULSE Catheter and TRUPULSE Generator with VARIPULSE Pro Software for Treating Persistent Atrial Fibrillation in Adults

What this Trial Is About

Researchers are evaluating the use of the pulsed field ablation PFA system, which includes the VARIPULSE catheter, TRUPULSE generator, and the new VARIPULSE Pro software, for treating participants with persistent atrial fibrillation PsAF. This condition involves an irregular, rapid heart rhythm lasting more than 7 days that does not stop on its own. The study aims to investigate the clinical workflow and effectiveness of this system during cardiac ablation procedures for PsAF. Participants selected for this study will undergo pulmonary vein isolation using the pulsed field ablation system with the specified devices and software. The ablation procedure is intended to manage symptomatic persistent atrial fibrillation, especially in those who have failed at least one antiarrhythmic drug. The study does not include a comparison group and focuses on a single group receiving the PFA treatment. During the study, participants will be monitored for several outcomes including acute procedural success during the ablation, durability of pulmonary vein isolation up to 3 months, and details such as the time and number of pulsed field applications. Safety assessments include monitoring serious and non-serious adverse events, neurological status through scales like the Mini Mental State Examination and NIH Stroke Scale, and MRI evaluations for cerebral emboli. Follow-up and testing will occur before, during, and up to 3 months after the ablation procedure, with the overall participation lasting several months.

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF